Abatacept Approved for Sub-Q Injection

A formulation of the rheumatoid arthritis drug abatacept (Orencia) that patients can self-inject subcutaneously has received FDA approval, its manufacturer said.

With the new approval, patients can now administer the biologic drug themselves at home, according to Bristol-Myers Squibb. Previously, abatacept was available only as an intravenous infusion.

The subcutaneous formulation is to be given as a 125-mg fixed dose weekly, preferably after an initial intravenous loading dose of 10 mg/kg. However, patients unable to receive the infusion may start immediately with the subcutaneous injections at the regular dose, the company said.

A clinical trial demonstrated that the subcutaneous form was not inferior to intravenous abatacept after six months of treatment with ACR 20 response (20% reduction in symptoms according to American College of Rheumatology criteria) as the primary outcome.

Adverse events with the subcutaneous version were similar to those seen with intravenous administration. About 3% of patients had local injection-site reactions, mostly mild and none serious.

Bristol-Myers Squibb emphasized that abatacept in either form should not be coadministered with other biologic anti-arthritis drugs because of increased rates of infections in clinical studies.

Abatacept is a fusion protein combining an antibody protein with the extracellular domain of CTLA-4, which inhibits T cell activation. The IV version is currently approved to treat moderate to severe rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in children at least 6-years-old.

The subcutaneous form has not been studied in children, the company noted.

It said the subcutaneous version should reach pharmacies in September.

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